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New NSF Warnings Added to Gadolinium Contrast Dye Labels

Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien’s Optimark are the gadolinium contrast dyes associated with the greatest risk of nephrogenic systemic fibrosis (NSF), according to a Food & Drug Administration (FDA) safety alert issued today. The labeling for these three gadolinium agents is being updated to warn that they are inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.

All gadolinium contrast dye labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration, the FDA said.

Gadolinium-based contrast dyes are intravenous drugs approved by the FDA for use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to help detect abnormalities of body organs, blood vessels, and other tissues. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF.

NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes

In a statement, the FDA said the label changes announced today are intended to help ensure gadolinium dyes are used appropriately, and that patients at risk for NSF who receive these agents are actively monitored for the development of the disease.

Is GE Trying to Stifle Omniscan Critic in the UK?

A Danish radiologist says GE Healthcare is using libel laws in the United Kingdom to stop his criticism of Omniscan.

For now, because of the libel claim against him, The Guardian says Henrick Thomsen has stopped lecturing in the UK. The doctor also claims patients in England are  being put at serious risk because he and other scientists are prevented from sharing their knowledge as a result of the way the libel courts in the country operate. (more…)

First NSF Trial Set for January

The litigation involving  gadolinium contrast dyes and nephrogenic systemic fibrosis is moving into high gear.  According to Law.com, a  Magnevist lawsuit against Bayer currently pending in California will be among the first to go to trial.

The California Magnevist lawsuit is scheduled for trial in January, and  is one of  20 to 30 NSF lawsuits in the state that have been consolidated before San Francisco Superior Court Judge Richard Kramer.  While this suit only names Bayer as a defendant, General Electric, the maker of Omniscan gadolinium contrast dye, is also a major defendant in the California litigation. (more…)

NSF Lawsuit Names Missouri Hospital

A kidney disease patient has filed a lawsuit against St. Luke’s Hospital in Chesterfield, Mo., claiming the hospital was negligent in administering contrast dyes to him during MRI and MRA procedures.   The plaintiff was diagnosed with  nephrogenic systemic fibrosis (NSF), a deadly disorder that affects people with kidney impairment who have been exposed to gadolinium agents.

According to the lawsuit,  the plaintiff was administered a gadolinium agent at St. Luke’s Hospital in Chesterfield, Mo. in January 2005 in conjunction with an MRI.  The plaintiff was administered a contrast agent and underwent magnetic resonance angiography (MRA) on Oct. 10, 2007, at St. Luke’s. On Nov. 6, 2007, another MRA, again requiring the use of a contrast agent, was performed on the plaintiff at the hospital. (more…)

NSF Risk From Gadolinium Highest for Dialysis, Kidney Transplant Patients

A new study published in the October issue of the Archives of Dermatology has found that dialysis patients and kidney transplant patients exposed to  gadolinium contrast dyes face a higher risk of developing the devastating disease, nephrogenic systemic fibrosis (NSF).

The study involved 94,917 patients exposed to gadolinium agents at the Mayo Clinic between January 1, 1999 and December 31, 2006.   Of that group, 3,779 patients were on hemodialysis, 1,694 patients had undergone a kidney transplant, and 717 patients had liver transplants.  A total of 61 patients had a clinical diagnosis of NSF. (more…)

Discovery Rules Set in NSF Multidistrict Litigation

The Multidistrict Litigation in U.S. District Court established for hundreds of  lawsuits filed against the makers of gadolinium contrast dyes by victims of Nephrogenic Systemic Fibrosis (NSF) has reached a new phase.  At a September 24 conference, ground rules for the consolidated discovery phase of hundreds of cases were established by the judge overseeing the litigation.

For the next Multidistrict Litigation conference, lawyers must provide product identification in approximately 75% of the cases where a plaintiff fact sheet has been exchanged prior to October 1 before the case can be designated for an early trial pool.  By November, attorneys for both sides must also choose 10 cases each  to undergo discovery. The 20 cases will be reduced to 10 by May 2009 for the court to begin case-specific expert discovery.  By January 23, lawyers for plaintiffs must also submit expert reports limited to any generic experts they may call in the initial trials.

(more…)

TennCare Will Pay for Woman’s NSF Treatment

TennCare will pay for a woman with Nephrogenic Systemic Fibrosis (NSF) to undergo a treatment that might save her life. TennCare,  Tennesee’s Medicaid  managed care program, had refused to do so for two years because it said the treatment was experimental.  But a Judge in April said it must pay, because the treatment is medically necessary, and the insurer has indicated it won’t fight the decision.

Like all people with NSF,  Jeannie Deason was a kidney patient who developed the condition after she was exposed to gadolinium contrast dyes that are used in MRI procedures. Deason’s NSF has progressed to the point where her legs and right arm have become frozen in a bent position. During the fight with TennCare her condition deteriorated to the point where she needs someone to stay with her 24 hours a day. Now she spends her days in bed, limbs throbbing, only getting up when her parents help her go to the bathroom. She even had to miss her daughter’s graduation. (more…)

Woman with NSF Sues Over Magnevist

Bayer-Schering has been named in a lawsuit filed by a woman who claims its Magnevist gadolinium contrast dye caused her to develop Nephrogenic Systemic Fibrosis (NSF). According to the lawsuit, the plaintiff received an injection of Magnevist gadolinium contrast dye on March 23, 2001. The Brooklyn Center, Minn. woman was diagnosed with NSF in February 2007.

The lawsuit, which also  names Bayer-Schering subsidiary Berlex Laboratories as a defendant, says that the plaintiff continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF. This has permanently disabled, disfigured and severely impaired the plaintiff. (more…)

General Electric Omniscan Blamed for NSF in Lawsuit

A lawsuit filed by a Philadelphia man alleges that General Electric Omniscan gadolinium contrast dye caused him to Philadelphia man to develop a devastating disease called Nephrogenic Systemic Fibrosis (NSF) The plaintiff in the General Electric Omniscan lawsuit is represented by the law firm of Parker Waichman LLP.

According to his lawsuit, Zbigniew Marcinczyk received two injections of Omniscan contrast dye in September and December 2005. Shortly after the administration of Omniscan, Marcinczyk developed NSF. The complaint states that Marcinczyk continues to suffer from the severe, debilitating and progressive fibrotic changes associated with NSF. NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. (more…)

NSF MRI Injures a Real Danger Faced by Kidney Patients Undergoing MRI

Nephrogenic Systemic Fibrosis (NSF) is a serious disease that anyone with a kidney disease. It has been associated with the use of gadolinium contrast dyes used in MRI prodedures. Unfortunately, there are no alternatives for gadolinium contrast dyes available at this time, and sometime such an MRI is truly necessary. For that reason, doctors must take added precautions to lessen the chance that kidney patients undergoing MRI with gadolinium contrast dyes develop NSF.

The Food & Drug Administration (FDA) has also warned that the use of gadolinium contrast dyes in a procedure call Magnetic Resonance Angiography (MRA) could put kidney patients at an even greater risk of developing NSF because these procedures often use far more gadolinium than a typical MRI. The FDA has not approved the use of gadolinium contrast dyes for use in MRA. (more…)

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